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There is no convincing evidence from [[randomized controlled trial]]s in the [[scientific literature]] that antineoplastons are useful treatments of cancer and the [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) has not approved these products for the treatment of any disease.<ref name=ACS>[http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/Patient/page2 Antineoplastons] ''National Cancer Institute''</ref> The [[American Cancer Society]] has stated that there is no evidence that these products have any beneficial effects in cancer and have recommended that people do not buy these products.<ref name=Antineoplastic1983>{{Cite journal | last = Antineoplastic | first = A. | year = 1983 | title = Antineoplastons | journal = CA Cancer J Clin | volume = 33 | issue = 1 | pages = 57–9 | doi = 10.3322/canjclin.33.1.57 | url = http://www.ncbi.nlm.nih.gov/pubmed/6401577 | pmid = 6401577 | postscript = <!--None-->}}</ref> A recent medical review described this treatment as a "disproven therapy".<ref>{{cite journal |author=Vickers A |title=Alternative cancer cures: "unproven" or "disproven"? |journal=CA Cancer J Clin |volume=54 |issue=2 |pages=110–8 |year=2004 |pmid=15061600 |doi= 10.3322/canjclin.54.2.110|url=http://caonline.amcancersoc.org/cgi/pmidlookup?view=long&pmid=15061600}}</ref>
Although no randomized controlled clinical trials have yet been performed, in Phase II FDA-supervised clinical trials for patients with high-grade, recurrent, and progressive brainstem glioma, "Antineoplastons contributed to more than a 5-year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients". <ref>Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma, [http://www.ncbi.nlm.nih.gov/pubmed/16484713t] ''PUB MED'' March 2006</ref>
The 2010 film ''Burzynski'' directed by Eric Merola, documents Burzynski's efforts to gain FDA approval for the therapy.<ref>{{Cite web|url=http://movies.nytimes.com/2010/06/04/movies/04burzynski.html|title=A Texas Doctor With a Possible Cancer Cure|date=2010-06-04|publisher=[[New York Times]]}} {{Cite web|url=http://www.netflix.com/Movie/Burzynski/70140534|title=Burzynski|date=2010|publisher=[[Netflix]]}} {{Cite web|url=http://www.imdb.com/title/tt1632703/|title=Burzynski|date=2010|publisher=[[Internet Movie Database]]}}</ref>
== Background ==
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